NCT06927999

An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: ARS Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).

Conditions

• Urticaria Chronic

Interventions

Type	Name	Description
DRUG	Placebo	Placebo solution nasal spray containing no active drug
DRUG	0.5 mg epinephrine	0.5 mg epinephrine per spray
DRUG	1 mg epinephrine	1 mg epinephrine per spray

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-04-15
• Last updated: 2025-10-02

Locations

3 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study